Monday, March 6, 1995
Experience leads us to be cautious about agents of change whose zeal for revolution overwhelms good sense. If Bill and Hillary Rodham Clinton's health care revolution turned out to be an ambush in broad daylight with a blackjack, then the GOP conservatives remind us of those impatient bully drivers who get on your tail at 70 mph and would just as soon force you off the road than pass safely on the left.
However, the conservatives get full credit for making it possible to debate virtually everything that not so long ago was out of bounds for serious policy discussion, including the FDA.
Last week, the Biotechnology Industry Organization introduced its slate of proposals aimed at redirecting FDA resources at drug approval and keeping the agency out of the information flow between drug makers and prescribers, as well as to eliminate the agency's jurisdiction over drug exports to countries that want them (see BioCentury Extra, Feb. 28).
In poking through BIO's position paper, which by now has been distributed throughout Capitol Hill, we concluded that beyond the specifics, the proposals ultimately raise questions about the FDA's mandate and whether it can be changed directly or through a combination of connivance and contrivance.
In particular, we found interesting two assertions pointing to a need for a
high level change in the agency's mission. According to BIO, "in some instances
the FDA's mission of protecting the public is being pursued without a requisite
recognition that it also plays an important role in the promotion of innovation
and the prompt approval of new therapies needed by seriously ill patients."
(Italics are ours.)
A new mandate
In addition, "BIO recommends initial steps to improving patient access to new therapies as part of transforming and renewing the FDA. Promotion of the public health, increased international competitiveness, and prompt revision of regulations are paramount goals of renewing the Food and Drug Administration